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Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
Radiant Research Incorporated
Chandler, Arizona, 85224 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hyperlipidemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Treated with a statin - Fasting LDL-C >=70mg/dL and triglycerides

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Pregnant or breastfeeding females - Cardiovascular or cerebrovascular event or
procedures during the past 90 days - Congestive heart failure NYHA class IV - Poorly
controlled hypertension

NCT02458287
Pfizer
Completed
Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia

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Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia
A 12 Week, Phase 3, Double-blind, Randomized, Placebo-controlled, Parallel Group Study To Assess The Efficacy, Safety, Tolerability And Actual Use Of Bococizumab And An Autoinjector (Pre-filled Pen) In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia
This study is a multicenter, randomized study in subjects with high cholesterol receiving statins to assess the efficacy to lower LDL-C, the safety, tolerability and actual use of bococizumab and an autoinjector (pre-filled pen).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hyperlipidemia
  • Biological: Bococizumab 150mg
    Bococizumab autoinjector (pre-filled pen) combination Product. 150mg every 2 weeks for 10 weeks, subcutaneous injection.
  • Biological: Bococizumab 75mg
    Bococizumab autoinjector (pre-filled pen) combination Product. 75mg every 2 weeks for 10 weeks, subcutaneous injection.
  • Biological: Bococizumab 150mg placebo
    Bococizumab placebo autoinjector (pre-filled pen) combination Product. 150mg placebo every 2 weeks for 10 weeks, subcutaneous injection.
  • Biological: Bococizumab 75mg placebo
    Bococizumab placebo autoinjector (pre-filled pen) combination product. 75mg placebo every 2 weeks for 10 weeks, subcutaneous injection.
  • Experimental: Bococizumab 150mg
    Bococizumab 150mg autoinjector (pre-filled pen)
    Intervention: Biological: Bococizumab 150mg
  • Experimental: Bococizumab 75mg
    Bococizumab 75mg autoinjector (pre-filled pen)
    Intervention: Biological: Bococizumab 75mg
  • Placebo Comparator: Bococizumab 150mg placebo
    Bococizumab 150mg placebo autoinjector (pre-filled pen)
    Intervention: Biological: Bococizumab 150mg placebo
  • Placebo Comparator: Bococizumab 75mg placebo
    Bococizumab 75mg autoinjector (pre-filled pen)
    Intervention: Biological: Bococizumab 75mg placebo
Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C; SPIRE Investigators. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. N Engl J Med. 2017 Apr 20;376(16):1517-1526. doi: 10.1056/NEJMoa1614062. Epub 2017 Mar 17.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
299
February 2016
February 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Treated with a statin - Fasting LDL-C >=70mg/dL and triglycerides <=400mg/dL

Exclusion Criteria:

  • Pregnant or breastfeeding females - Cardiovascular or cerebrovascular event or procedures during the past 90 days - Congestive heart failure NYHA class IV - Poorly controlled hypertension
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02458287
B1481046
SPIRE-AI ( Other Identifier: Alias Study Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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